Is hysteroscopic resection of submucous myomas under procedural sedation with propofol (PSA) in an outpatient setting a cost-effective alternative for hysteroscopic myomectomy performed under general anesthesia in the operation room?
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Menstrual cycle and uterine bleeding disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
complete resection
Secondary outcome
Costs, pain, menstrual blood loss (PBAC score), quality of life, return to
daily activities/work, hospitalization, (post)operative complications,
re-interventions.
Background summary
Myomas are a frequent finding in patients with abnormal uterine bleeding. The
Dutch Guideline *Heavy menstrual bleeding* recommends hysteroscopic myomectomy
as treatment of first choice in case of symptomatic submucous myomas. In the
current situation, patients are admitted into daycare and they are operated
under general anesthesia. In the last decades, there has been a trend in
hysteroscopic surgery to move from a traditional operating theatre with general
anesthesia to an outpatient setting. Procedural sedation is used for a wide
variety of interventional procedures in multiple settings outside the operation
room. For resection of myomas, however, procedural sedation is currently not
commonly used. We expect that hysteroscopic myomectomy using procedural
sedation is equally effective as under general anesthesia. A significant cost
reduction is expected.
Study objective
Is hysteroscopic resection of submucous myomas under procedural sedation with
propofol (PSA) in an outpatient setting a cost-effective alternative for
hysteroscopic myomectomy performed under general anesthesia in the operation
room?
Study design
Multicenter randomised controlled trial, with a cost effective analysis
alongside it.
Non-inferiority study. With 205 women randomized we have 90% power to
demonstrate non-inferiority, based on an estimated 2,5% incomplete resections
in both groups, with an non-inferiority upper limit of 10%, an alpha of 0.025
and a drop-out rate of 10%.
Intervention
hysteroscopic myomectomy under procedural sedation with propofol compared to
hysteroscopic myomectomy under general anesthesia.
Study burden and risks
There are no additional risks involved for patients participating in this study.
Procedural sedation is used for a wide variety of interventional procedures in
multiple settings outside the operation room and is considered to be a safe
procedure. Hysteroscopic myomectomy is an effective and safe procedure. It is
performed by an experienced surgeon by standard procedure. The procedure is not
influenced by the type of anesthesia used.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
- Women with a minimum age of 18 years
- Symptomatic type 0 or I submucous myomas
- Maximum number of submucous myomas: 3
- Maximum diameter of submucous myomas: 3,5 cm
- American Society of Anesthesiologist class 1 or 2
Exclusion criteria
- Women aged under 18 years
- Inability to understand Dutch or English
- American Society of Anesthesiologist class 3 or 4
- Clotting disorders
- Severe anemia (Hb under 5.0 mmol/l)
- > 3 submucous myomas
- diameter of submucous myoma > 3,5 cm
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54779.015.15 |